FDA.reportPublic FDA data

WoodyKnows

Primary DI
00850040983012
Brand
WoodyKnows
Company
M&M Pure Air Systems LLC
Model
BP2
Published
2026-05-19
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040983012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040983012008500409830128500409830120850040983012

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Regulatory Flags#

DUNS number
080704335
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040983036WoodyKnowsMT12026-05-20
00850040983043WoodyKnowsMT22026-05-20
00850040983005WoodyKnowsBP12026-05-19
00850040983029WoodyKnowsBP32026-05-19
00850040983050WoodyKnowsSD12026-05-19
00850040983067WoodyKnowsSD22026-05-19
00850040983074WoodyKnowsSD32026-05-19
00850040983081WoodyKnowsUB12026-05-19
00850040983098WoodyKnowsUB22026-05-19
00850040983104WoodyKnowsUB32026-05-19
00850040983111WoodyKnowsND12026-05-19
00850040983128WoodyKnowsND22026-05-19
00850040983135WoodyKnowsND32026-05-19
00850040983142WoodyKnowsND42026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850040983005WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
00850040983029WoodyKnowsM&M Pure Air Systems LLCMRI2026-05-19
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00645517898766TrulifeTRULIFE LIMITEDMRI2025-09-11
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00810178881567CoreTechVIVE HEALTH LLCMRI2025-05-19
10810178881564CoreTechVIVE HEALTH LLCMRI2025-05-19
04823097721872"TM ""Rehabilitimed"" L-4M-3 S Comfort"REABILITIMED TOVMRI2025-05-17